Trial Outcomes & Findings for Panitumumab and Gemcitabine in Relapsed Ovarian Cancer (NCT NCT01296035)

NCT ID: NCT01296035

Last Updated: 2015-08-25

Results Overview

Documentation of known measurable or evaluable disease parameters after every 2 cycles of treatment. If any patient is withdrawn for the study prior to completion of therapy a repeat evaluation will be done at that time.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 8 participants
• Primary outcome timeframe: Every 8 weeks while on-study
• Results posted on: 2015-08-25

Participant Flow

Participant milestones

Measure	Panitumuab and Gemcitabine Panitumumab: Panitumumab 2.5 mg/kg on D1, D8, D15, and D22 and Gemcitabine 800 mg/m2 on D1, D8, and D15 of each 28 day cycle.
Overall Study STARTED	8
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Panitumuab and Gemcitabine Panitumumab: Panitumumab 2.5 mg/kg on D1, D8, D15, and D22 and Gemcitabine 800 mg/m2 on D1, D8, and D15 of each 28 day cycle.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Panitumumab and Gemcitabine in Relapsed Ovarian Cancer

Baseline characteristics by cohort

Measure	Panitumuab and Gemcitabine n=8 Participants Panitumumab: Panitumumab 2.5 mg/kg on D1, D8, D15, and D22 and Gemcitabine 800 mg/m2 on D1, D8, and D15 of each 28 day cycle.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=93 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants
Sex: Female, Male Female	8 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Region of Enrollment United States	8 participants n=93 Participants

PRIMARY outcome

Timeframe: Every 8 weeks while on-study

Population: Due to the small number of participants, data were not collected as planned

Documentation of known measurable or evaluable disease parameters after every 2 cycles of treatment. If any patient is withdrawn for the study prior to completion of therapy a repeat evaluation will be done at that time.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Every 4 weeks while on-study, up to 24 weeks

Population: Please see results section. In short, there were 3 serious adverse events (1 thromboembolic, 1 hypomagnesemia, 1 bowel obstruction). Additional adverse events included (in decreasing order) rash, fatigue, anemia, edema, thrombocytopenia, abdominal pain, epistaxis, hypocalcemia, and calciphylaxis

Adverse events (AEs) will be recorded during the duration of the trial, whether or not the events are considered related to medication. All AEs considered to be related to trial therapy will be followed for resolution, including into the post-treatment period.

Outcome measures

Measure	Panitumuab and Gemcitabine n=33 events Panitumumab: Panitumumab 2.5 mg/kg on D1, D8, D15, and D22 and Gemcitabine 800 mg/m2 on D1, D8, and D15 of each 28 day cycle.
Adverse Events, Measured by Active Version of the NCI Common Toxicity Criteria	8 participants

Adverse Events

Panitumuab and Gemcitabine

Serious events: 3 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	Panitumuab and Gemcitabine n=8 participants at risk Panitumumab: Panitumumab 2.5 mg/kg on D1, D8, D15, and D22 and Gemcitabine 800 mg/m2 on D1, D8, and D15 of each 28 day cycle.
Vascular disorders Thromboembolic event	12.5% 1/8 • Number of events 1
Investigations Hypomagnesemia	12.5% 1/8 • Number of events 2
Gastrointestinal disorders Bowel obstruction	12.5% 1/8 • Number of events 3

Other adverse events

Measure	Panitumuab and Gemcitabine n=8 participants at risk Panitumumab: Panitumumab 2.5 mg/kg on D1, D8, D15, and D22 and Gemcitabine 800 mg/m2 on D1, D8, and D15 of each 28 day cycle.
Skin and subcutaneous tissue disorders Rash	75.0% 6/8 • Number of events 6
Investigations Platelet count decreased	37.5% 3/8 • Number of events 4
General disorders Fatigue	75.0% 6/8 • Number of events 6
Investigations Anemia	62.5% 5/8 • Number of events 5
Investigations Hypocalcemia	12.5% 1/8 • Number of events 1
General disorders Abdominal pain	25.0% 2/8 • Number of events 2
General disorders Epistaxis	25.0% 2/8 • Number of events 2
Skin and subcutaneous tissue disorders Edema-limbs	37.5% 3/8 • Number of events 3
Skin and subcutaneous tissue disorders Calciphylaxis	12.5% 1/8 • Number of events 1

Additional Information

Director of Clinical Trials

Women & Infants Hospital

Phone: 401-274-1122

Email: jmari@wihri.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place